Clinical trials: Cystic Fibrosis (CF)
Cystic Fibrosis
Effects of a Partially Supervised Conditioning Program in CF
Physical activity and exercise have become an accepted and valued component of Cystic Fibrosis care. Regular physical activity and exercise can slow the rate of decline of pulmonary function, improve physical fitness, and enhance…
- Trial name
- ACTIVATE-CF (NCT01744561)
- Testing
- Exercise Intervention
- Where
- 28 sites in United States, Austria and 6 more
- Volunteers
- 155 people
- Sponsor
- Wuerzburg University Hospital
Cystic Fibrosis
Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study
Protocol 0000498: Multicenter, open label study to evaluate the effect of sustained RELiZORB (immobilized lipase) cartridge use during enteral feeding on fat absorption, as well as safety and tolerability of sustained RELiZORB…
- Trial name
- ASSURE (NCT02750501)
- Testing
- RELiZORB (immobilized lipase) cartridge, Impact Peptide 1.5
- Where
- 10 sites in United States
- Volunteers
- 49 people
- Sponsor
- Alcresta Therapeutics, Inc.
Cystic Fibrosis
Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules
The purpose of this study is to validate the user interface of TOBI Podhaler by establishing that the product can support safe and effective use for the intended users
- Trial name
- NCT03502070
- Testing
- Tobi Podhaler
- Where
- 9 sites in United States
- Volunteers
- 47 people
- Sponsor
- Mylan Inc.
Cystic Fibrosis
Comparative Analysis of CO2 Monitoring Methods in Patients With CF Undergoing General Anesthesia
Four methods are routinely used to monitor CO2 in patients. End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia.
- Trial name
- NCT03734822
- Testing
- End tidal CO2 (EtCO2), Transcutaneous CO2 (TCO2), Capillary CO2 (CapCO2)
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Nationwide Children's Hospital
Cystic Fibrosis
HERO-2: Home-Reported Outcomes With CFTR Modulator Therapy
This is an observational cohort study, using data from Folia Health and the Cystic Fibrosis Foundation Patient Registry (CFFPR).
- Trial name
- NCT04798014
- Where
- United States
- Volunteers
- 860 people
- Sponsor
- Indiana University
Cystic Fibrosis
Scandinavian Cystic Fibrosis Azithromycin Study
In patients with Cystic Fibrosis, recurrent airway infection caused by Pseudomonas aeruginosa ultimately leads to chronic airway infection.
- Trial name
- NCT00411736
- Where
- 8 sites in Denmark, Norway and 1 more
- Volunteers
- 45 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Alteration in Quality of Life of CF Patients, Following Change of Treatment From Antibiotic Inhalation to Antibiotic Inhaler
Switching From Tobramycin Inhalation Treatment to Tobramycin Inhaler Treatment: The Effect on CF Patients' Adherence and Quality of Life
Pseudomonas is a common and virulent respiratory bacteria in patients with Cystic Fibrosis (CF). With time, the infection with Pseudomonas becomes chronic and very difficult to eradicate.
- Trial name
- NCT01749644
- Where
- Israel
- Volunteers
- 40 people
- Sponsor
- Sheba Medical Center
Cystic Fibrosis
Lum-Iva-biota: Exploring the Respiratory Mycobiota and Microbiota Profile in French CF Patients Taking Lumacaftor-Ivacaftor
n2015, VERTEX company - producing already KALYDECO (IVACAFTOR, VX-770) potentiator molecule that is recommended for the treatment of CF patients aged ≥ 6 y, with CFTR mutation altering the channel regulation (class III mutations)…
- Trial name
- Lum-Iva-Biota (NCT03565692)
- Testing
- the lung mycobiota and microbiota profile, the gut mycobiota and microbiota profile
- Where
- 8 sites in France
- Volunteers
- 250 people
- Sponsor
- University Hospital, Bordeaux
Cystic Fibrosis
COVID-19 Antibody Responses in Cystic Fibrosis
Coronavirus disease 2019 (COVID-19) which is caused by the virus SARS-CoV-2 has resulted in an ongoing global pandemic. It is unclear whether the relatively low number of reported cases of COVID-19 in people with CF (pwCF) is due…
- Trial name
- CAR-CF (NCT05052294)
- Where
- 2 sites in Czechia
- Volunteers
- 50 people
- Sponsor
- University Hospital, Motol
Cystic Fibrosis in Children
Response to CFTR Modulators in CF Patients Under 18 Years
CFTR modulators should improve the prognosis of Cystic Fibrosis. Identifying patients under the age of 18 responding to CFTR modulators as well as detecting possible toxicity is an important medical objective given the potential…
- Trial name
- MODUL-CF (NCT04301856)
- Testing
- CFTR Modulators
- Where
- France
- Volunteers
- 600 people
- Sponsor
- Societe Francaise de la Mucoviscidose
Digestive System Diseases, Pancreatic Disease
Open Label Safety Study of DCI-1020 in Pediatric Cystic Fibrosis (CF) Patients
Hypothesis:DCI 1020 capsules are safe and effective in treating exocrine pancreatic insufficiency in CF patients <= 2 years of age.
- Conditions
- Digestive System Diseases, Pancreatic Disease, Cystic Fibrosis, Exocrine Pancreatic Insufficiency
- Trial name
- NCT00663975
- Testing
- DCI 1020
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Digestive Care, Inc.
Cystic Fibrosis
Technology-enabled Patient Support System for Self-management of CF
This project will test a technology-enabled patient support system (PSS) as a self-management tool for children with CF and their family caregivers.
- Trial name
- NCT03910881
- Testing
- Open-platform patient support system (PSS) app
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Alabama at Birmingham
Cystic Fibrosis (CF), Cystic Fibrosis Pulmonary Exacerbation
Identifying the Causes and Risk Factors of Pulmonary Exacerbations in Cystic Fibrosis
The CF-Tracker study is a community surveillance study, designed to understand the causes of exacerbations in people with cystic fibrosis (CF) (pwCF).
- Trial name
- CF-Tracker (NCT06940531)
- Where
- 18 sites in United Kingdom
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Alexander Horsley
Asthma, Cystic Fibrosis
Breath Analysis in Children by New Point-of-care Instruments
In this study new hand-held devices for measuring exhaled breath will be tested in children with asthma, CF, and healthy controls. Main objectives will be feasibility and discriminative value of these techniques.
- Trial name
- NCT03377686
- Testing
- inflammation markers in exhaled breath
- Where
- Netherlands
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Maastricht University Medical Center
Cystic Fibrosis, Cystic Fibrosis Liver Disease
Real World Clinical Outcomes With Novel Modulator Therapy Combinations in People With CF (RECOVER)
RECOVER is a prospective, multicenter observational study designed to measure the real world clinical effectiveness of elexacaftor/tezacaftor/ivacaftor (ETI) triple combination therapy in people with cystic fibrosis initially…
- Conditions
- Cystic Fibrosis, Cystic Fibrosis Liver Disease, Cystic Fibrosis in Children, Adherence, Medication
- Trial name
- RECOVER (NCT04602468)
- Testing
- Elexacaftor/Tezacaftor/Ivacaftor
- Where
- 7 sites in Ireland, United Kingdom
- Volunteers
- 206 people
- Sponsor
- Royal College of Surgeons, Ireland
Cystic Fibrosis
Study About Complications of Totally Implanted Venous Access Devices (TIVADs) in People With Cystic Fibrosis (CF)
Pulmonary infections are the major cause of mortality and morbidity in cystic fibrosis (CF); patients frequently have to take antibiotics which often cannot be given orally or by aerosol but have to be administered intravenously.
- Trial name
- NCT00670579
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- University of Florence
Cystic Fibrosis in Children
Effect of Lumacaftor/Ivacaftor in Children With Cystic Fibrosis Homozygote for F508del on Small Airway Function
To obtain prospective real world data of the effect of lumacaftor/ivacaftor or tezacaftor/ ivacaftor on small airway disease in children aged 6-18 years with cystic fibrosis (CF) homozygous for F508del.
- Trial name
- ROOTS (NCT04138589)
- Where
- 2 sites in Germany, Netherlands
- Volunteers
- 30 people
- Sponsor
- University Medical Center Groningen
Cystic Fibrosis, Non-CF Bronchiectasis
Regional Phenotyping of CF and Non-CF Bronchiectasis
The Investigators propose to study pediatric subjects who are diagnosed with cystic fibrosis (CF) and patients with non-CF bronchiectasis, with the goal of developing markers of CF lung disease severity, progression, and therapy…
- Trial name
- NCT04793867
- Testing
- Xenon
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Cystic Fibrosis
Evaluation of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis (CF) Participants 12 to Less Than 24 Months of Age
The study evaluates the pharmacokinetics (PK), safety, tolerability, pharmacodynamics (PD), and efficacy of ELX/TEZ/IVA in CF participants 2 to less than (<) 24 months of age.
- Trial name
- NCT05882357
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 19 sites in Australia, Canada and 5 more
- Volunteers
- 67 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
An Interactive Program to Improve Care for Children With CF
The purpose of this study is to evaluate the impact of an internet based program for children and families (CF.DOC) with Cystic Fibrosis on health outcomes.
- Trial name
- NCT00185549
- Testing
- CF. DOC
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Stanford University